enGene Holdings Inc., a clinical-stage, non-viral gene-based immunotherapy company, has announced that its lead investigational therapy, detalimogene voraplasmid (detalimogene), has been granted Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. Food and Drug Administration (FDA). This designation is aimed at expediting the development and review of therapies addressing serious conditions with unmet medical needs. The RMAT designation for detalimogene highlights its potential to treat high-risk, Bacillus Calmette-Guérin $(BCG)$-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS). This provides enGene with regulatory advantages such as early engagement with the FDA and potential for priority and rolling review. The designation is based on preliminary results from the ongoing pivotal LEGEND study, showcasing promising clinical activity and tolerability. Detalimogene is designed for easy administration in urology clinics, offering a potentially transformative option for patients with limited treatment choices.